A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
ConditionEGFR Inhibitor-associated Rash
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzitra Inc.
About this trial
The goal of this randomized clinical trial is to learn if topical treatment with ATR04-484 can treat skin rash in patients undergoing EGFR inhibitor (EGFRi) therapy. The primary goal of the study is to determine safety and tolerability of ATR04-484, and the secondary goal of the study is to assess efficacy signals of ATR04-484. Researchers will compare treatment of ATR04-484 to its vehicle. Participants will:
* Apply ATR04-484 or vehicle daily for 28 days * Visit the clinic periodically for evaluation and sample collection
Eligibility criteria
Qualifiers
Adults ≥18 years of age
Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected)
Disqualifiers
Significant skin disease other than EGFRi-related dermal toxicity
Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 14 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 14 days prior to baseline
Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period
Trial design
Treatments tested in this trial
- ATR04-484
- Vehicle
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Azitra Inc.
Lead sponsor
Prosoft Clinical
Collaborator
Source ClinicalTrials.gov